Preparation of FDA Submissions and Communicating with the FDA | Seminar 2018

Overview:

Why you should attend:

• What do the regulations say?
• Navigate the FDA drug and device approval system
• Prepare, construct and submit well-written IND, NDA, BLA, PMA, 510(k) and IDE submissions and regulatory filings
• Navigate the FDA review process
• Identify the required regulations and guidance documents for drug and biologic submissions
• Use regulations and guidance documents to outline and construct a variety of drug and biologic submissions
• Formulate a working knowledge of regulatory submissions, publishing, and style guides
• Create checklists that encompass timelines and sections needed from contributors
• Strategic and technical guidance for drug and medical product development and regulatory review
• Regulatory policy guidance
• Regulatory Strategy planning and communications
• FDA 510(k) submissions for obtaining FDA clearance
• FDA Investigational Device Exemption (IDE) submissions for US clinical studies
• FDA Requests for Classification and Requests for Determination
• FDA Pre-Submission (Pre-sub) meetings
• Attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion
• Challenges and possible solutions will be discussed, and examples will demonstrate how the requirements can be put into practice
• Where does the PMA fit into the medical device universe (e.g. how to decide whether to use the PMA or another pathway to market)?
• How can the PMA be your friend (e.g. when a PMA is actually preferred over a 510k)?
• What are the 'required contents' of a PMA submission?
• How to decide amongst the types of PMA submissions (e.g. traditional, modular, streamlined, etc. and what are the advantages and disadvantages of each)?
• What is the Summary of Safety and Effectiveness Data (SSED) and how is it used?
• What are the differences in clinical trials for devices compared to drugs and biologics?
• How can we design device clinical trials to maximize our success to market?
• When can we combine pathways via label expansion?
• Want to avoid the PMA? Consider the De Novo – using classification to your advantage!
• How to use the PMA beyond the device world? i.e., using combination products: PMA+NDA/PMA+BLA, etc.
• Define basic terms related to device research
• Locate applicable regulations
• Determine when an IDE is required
• Describe Sponsor & Investigator responsibilities
• Know contents and submission process for an IDE Application
• Conduct IDE, PMA and 510(k) submission management activities
• Regulatory strategy and regulatory planning for effective IND, NDA, ANDA and BLA submissions
• Preparing for and conducting effective and efficient FDA meetings and communications
• When to address and submit Post-Approval Supplements
• Review and discuss pain points, challenges and solutions